PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.
NCT06274047 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-05-20
Summary
1. Personalize treatment for prostate cancer based on how aggressive the disease is and
2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.
Conditions
- Androgen Axis Suppression
- Prostatectomy
- Prostate Cancer
Interventions
- DRUG
-
Apalutamide
Given by PO
- DRUG
-
Androgen Deprivation Therapy
Given by PO
Sponsors & Collaborators
-
Janssen Scientific Affairs, LLC
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Karen Hoffman, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-10
- Primary Completion
- 2027-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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